Recommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immuno deficiency Virus

14

MMWR

August 5, 1994

Infant Monitoring
A complete blood count and differential should be performed at birth as a baseline
evaluation. Repeat measurements of hemoglobin are recommended at 6 and 12
weeks of age. ZDV should be administered with caution to infants born with severe
anemia (hemoglobin <8 gm/dL), and treatment of the anemia and intensive monitoring are warranted if the drug is administered.
Previously published guidelines contain recommendations for diagnosing HIV
infection in infants and for initiating PCP prophylaxis and antiretroviral therapy for
those who are infected (53-55). The potential efficacy of ZDV therapy for HIV-infected
children who require antiretroviral therapy and who received ZDV in utero and during
early infancy has not been determined. A specialist in pediatric HIV infection may be
consulted if therapy is necessary for infected children whose mothers received ZDV
during pregnancy. Further research is needed to describe the response to therapy and
progression of disease in such infants.
POTENTIAL LONG-TERM EFFECTS OF ZDV THERAPY FOR
MOTHERS AND INFANTS AND RECOMMENDATIONS FOR
FOLLOW-UP
Discussion
Observational data about the pregnancy outcomes of women who receive ZDV
during pregnancy are being collected through the Antiretroviral Pregnancy Registry.
The purpose of the registry is to provide surveillance for possible teratogenicity
among infants born to women who received ZDV during pregnancy. Health-care
providers can register such patients by calling the registry at [phone], extension
8465, in the United States or [phone] outside the United States. Written reports
are available from Antiretroviral Pregnancy Registry, RO. Box 12700, Research Triangle Park, NC 27709.
Concerns about the potential long-term adverse effects among women include
development of ZDV-resistant virus when ZDV therapy is used intermittently to reduce
perinatal transmission, particularly during more than one pregnancy, and the potential effect such resistance could have on disease progression for the woman. Although
results of studies have demonstrated an association between emergence of ZDV resistance and total duration of ZDV exposure, none of the study designs has specifically
addressed the effect of intermittent therapy on development of resistance.
Continued follow-up of the women who participated in ACTG Protocol 076 and of
their infants is planned. A protocol to provide prospective evaluation of the health of
the women enrolled in ACTG Protocol 076 is being designed by the Women's Health
Committee of the ACTG. This protocol will evaluate virologic, immunologic, and clinical parameters among participating women.
Data are insufficient to address any effect that exposure to ZDV in utero might have
on risk for neoplasia or organ system toxicities. ACTG Protocol 219 is an ongoing
study designed to provide prospective evaluation for children who have been exposed
through ACTG protocols to antiretroviral agents in utero or to HIV vaccines until they
are 21 years of age. This protocol will provide intensive evaluation of multiple organ